In vitro dissolution tests – DissolvIt
DissolvIt® dissolution studies de-risk your R&D work by ranking and identifying the right drug candidates – at an early stage.
For more than 10 years DissolvIt has provided clients with head-to-head dissolution and absorption data of their compounds compared to the originator product, providing insight into the compounds’ behavior in clinical PK trials.
In vitro dissolution tests – DissolvIt
- In vitro (and non-biological) simulation of particle dissolution and absorption using an artificial air-blood barrier
Reveals the effect on dissolution of
- Change of CMO on APIs
- Different micronization methods
- Different formulations (e.g. carrier-based vs composite, free-base vs salt, etc)
- Composition (crystalline vs amorphous)
Benefits
- High discriminatory power: Complex generics: comparison of test items to RLD
- High potential correlation to PK curves: Selection of most suitable production batches to PK trials
* E. Selg at al., Dry Powder Inhalation Exposures of the Endotracheally Intubated Rat Lung, Ex Vivo and In Vivo: The Pulmonary Pharmacokinetics of Fluticasone Furoate, JOURNAL OF AEROSOL MEDICINE AND PULMONARY DRUG DELIVERY Volume 26, Number 0, 2012
** M. Sakagami, In vitro, ex vivo and in vivo methods of lung absorption for inhaled drugs, Advanced Drug Delivery Reviews 161–162 (2020) 63–74
*** P. Gerde et al., In Vitro to ex Vivo/In Vivo Correlation (IVIVC) of dissolution kinetics from inhaled particulate solutes using air/blood barrier models: relation between in vitro design, lung physiology and kinetic output of models, Jour Aerosol Science, 151 (2021)
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DissolvIt®
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IRS Brochure – Inhalation Research Services
DissolvIt® – Technical Specifications
Delivers
- Full aerosol characterization
- Both dissolution and absorption data for ranking of candidate drugs and comparison of generic candidates versus reference drugs
- Absorption profiles with Cmax and tmax resembling clinical absorption profiles
- Light microscope photos and/or video of real-time dissolution before/during dissolution
- SEM photos of deposited particles
- Full report including: Cmax and tmax, area under the curve (AUC), raw and normalized data
- High resolution curves (over 20 sampling points in time)